EMEA-000087-PIP01-07-M05

Key facts

Invented name
Gilenya
Active substance
Fingolimod (hydrochloride)
Therapeutic area
Neurology
Decision number
P/0050/2017
PIP number
EMEA-000087-PIP01-07-M05
Pharmaceutical form(s)
hard capsule
Condition(s) / indication(s)
Treatment of multiple sclerosis
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
E-mail: paediatric.enquiries@novartis.com
Tel. +41 613241111
Fax: +41 613248001
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000087-PIP01-07-M05
Compliance opinion date
10/11/2017
Compliance outcome
positive

Decision

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